Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
110 participants
INTERVENTIONAL
2005-09-30
2008-02-29
Brief Summary
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Detailed Description
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In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Vitamin D
Eligibility Criteria
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Inclusion Criteria
* Inactive Crohn's disease for at least 4 weeks
* Crohn's Disease Activity Index (CDAI) \< 150
* C-reactive protein within normal range
* Serum albumin within normal range
Exclusion Criteria
* Short bowel syndrome
* Pregnancy
18 Years
90 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Principal Investigators
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Jens F. Dahlerup, MD, DrMedSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital, Department V
Aarhus, , Denmark
Hospital of Horsens
Horsens, , Denmark
Hospital of Randers
Randers, , Denmark
Hospital of Silkeborg
Silkeborg, , Denmark
Countries
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Other Identifiers
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2005-001216-50
Identifier Type: -
Identifier Source: org_study_id